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Daclatasvir + Sofosbuvir +/- Ribavirin in Genotypes 1-3 A1444-040 Trial

Phase 2a. Treatment Naïve and Treatment Experienced. Daclatasvir + Sofosbuvir +/- Ribavirin in Genotypes 1-3 A1444-040 Trial. Sulkowski MS, et al. N Engl J Med. 2014;370:211-21. Daclatasvir + Sofosbuvir + /- Ribavirin for HCV GT 1-3 A1444 -040 Trial : Features.

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Daclatasvir + Sofosbuvir +/- Ribavirin in Genotypes 1-3 A1444-040 Trial

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  1. Phase 2a Treatment Naïve and Treatment Experienced Daclatasvir+ Sofosbuvir +/- Ribavirin in Genotypes 1-3A1444-040 Trial Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  2. Daclatasvir + Sofosbuvir +/-Ribavirin for HCVGT 1-3A1444-040 Trial: Features Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  3. Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3A1444-040 Design: Treatment-Naïve 24 Week Rx 0 12 24 36 Week n =16 Rx Naïve GT 2 or 3n = 44 SVR12 SOF × 7 days, then DCV + SOF n = 14 SVR12 DCV + SOF n = 14 SVR12 DCV + SOF + RBV n =15 Rx Naïve GT 1a/1bn = 44 SVR12 SOF × 7 days, then DCV + SOF n = 14 SVR12 DCV + SOF n = 15 SVR12 DCV + SOF + RBV Drug DosingDaclatasvir (DCV): 60 mg once dailySofosbuvir (SOF): 400 mg once dailyRibavirin (RBV): GT1, given weight-based and divided bid(1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg)Ribavirin (RBV): GT 2,3(800 mg/day) N =14 Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  4. Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3Design: GT1 Treatment-Naïve & Experienced 12 Week Rx 0 12 24 Week Rx Naïve GT 1a/1bn = 82 n = 41 SVR12 DCV + SOF n = 41 SVR12 DCV + SOF + RBV Rx Experienced GT 1a/1bPrior Boceprevir- or Telaprevir failuren = 41 n = 21 SVR12 DCV + SOF n = 20 SVR12 DCV + SOF + RBV Drug DosingDaclatasvir (DCV): 60 mg once dailySofosbuvir (SOF): 400 mg once dailyRibavirin (RBV): GT1, given weight-based and divided bid(1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg)Ribavirin (RBV): GT 2,3(800 mg/day) N =14 Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  5. Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3A1444-040 Treatment-Naïve 24 Week Rx: Results 0 12 24 36 Week n =16 Rx Naïve GT 2 or 3n = 44 SVR12 = 88% SOF × 7 days, then DCV + SOF n = 14 SVR12 = 93% DCV + SOF n = 14 SVR12 = 86% DCV + SOF + RBV n =15 Rx Naïve GT 1a/1bn = 44 SVR12 = 100% SOF × 7 days, then DCV + SOF n = 14 SVR12 = 100% DCV + SOF n = 15 DCV + SOF + RBV SVR12 = 100% Drug DosingDaclatasvir (DCV): 60 mg once dailySofosbuvir (SOF): 400 mg once dailyRibavirin (RBV): GT 1, given weight-based and divided bid(1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg)Ribavirin (RBV): GT 2,3(800 mg/day) N =14 Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  6. Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3A1444-040 Treatment-Naïve 24 Week Rx: Results 14/16 13/14 12/14 15/15 14/14 15/15 Treatment-Naïve: GT 2 or 3 Treatment-Naïve: GT 1a or 1b DCV = daclatasvir; SOF = sofosbuvir; RBV = ribavirin Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  7. Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3GT1 Treatment-Naïve & Experienced 12 Week Rx: Results 0 12 24 Week Rx Naïve GT 1a/1bn = 82 n = 41 SVR12 = 100% DCV + SOF n = 41 SVR12 = 100% DCV + SOF + RBV Rx Experienced GT 1a/1bPrior Boceprevir- or Telaprevir failuren = 41 n = 21 SVR12 = 90% DCV + SOF n = 20 SVR12 = 95% DCV + SOF + RBV Drug DosingDaclatasvir (DCV): 60 mg once dailySofosbuvir (SOF): 400 mg once dailyRibavirin (RBV): GT1, given weight-based and divided bid(1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg)Ribavirin (RBV): GT 2,3(800 mg/day) N =14 Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  8. Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3GT1 Treatment-Naïve & Experienced 12 Week Rx: Results 41/41 41/41 19/21 19/20 Treatment-Naïve: GT 1a or 1b Treatment-Experienced: GT 1a or 1b DCV = daclatasvir; SOF = sofosbuvir; RBV = ribavirin Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  9. Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3Trial: Conclusions Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  10. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Onlinewww.hepatitisc.uw.edu Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.

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